NCT05674409 Brief Family Involved Treatment Telehealth
| NCT ID | NCT05674409 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of South Carolina |
| Condition | Alcohol Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2023-03-13 |
| Primary Completion | 2028-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2023-03-13 with a primary completion date of 2028-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Improving alcohol use disorder (AUD) treatment among Veterans is a national public health problem. The rate of AUD among Veterans is twice that of civilians, with up to 50% of Veterans having AUD. Family-based AUD programs are rarely undertaken in busy treatment clinics, and Veterans with problem drinking behavior or AUD are commonly excluded from couple therapies. As a result, there is a need to develop effective family AUD treatments that are both brief and highly accessible to Veterans. The purpose of this study is to evaluate a new treatment add-on called Brief Family-Involved Treatment (B-FIT), which will be delivered via telehealth among Veterans engaged in alcohol-based treatment/therapy. This study is an 12-week, Stage-II, open randomized controlled trial examining B-FIT in combination with treatment as usual (TAU), (in this case B-FIT+ Cognitive Behavioral Therapy treatment) as compared to TAU alone (CBT treatment).Veterans and their treatment companion (family member, partner, friend) will complete weekly assessments during the treatment phase in addition to 3 \& 6 month follow-up assessments, all via telehealth.
Eligibility Criteria
Inclusion Criteria: * Participants will be 200 Veterans and a family member, plus their treatment companion, a concerned partner or friend (total N=400; 50% women veterans) aged 21 or older. Inclusion criteria for Veterans require that they: 1. Meet diagnostic criteria for current moderate to severe alcohol use disorder (AUD) with 2 or more heavy drinking days (\>5 for men, \>4 for women) in the 60 days prior to enrollment 2. Have an adult family member/treatment companion who is willing to participate 3. Demonstrate cognitive functioning sufficient to provide informed consent and participate accurately (≥ 26 on the Mini-Mental Status Exam \[MMSE\]) 4. Maintain a stable dose of psychotropic medications for at least 4 weeks before enrollment. Concurrent drug use disorders are acceptable provided alcohol is the Veteran's primary substance of choice. Drug use will be measured weekly and controlled for in statistical analyses if needed. Inclusion criteria for the family member/treatment companion require that they: 1. Are not receiving or seeking treatment for their own alcohol or drug problem 2. Report total Alcohol Use Disorders Identification Test (AUDIT) scores \<8 3. Report total Drug Abuse Screening Test (DAST-10) scores \<3. Exclusion Criteria: Exclusion criteria for all participants include: 1. History of or current psychotic or bipolar disorder 2. Alcohol withdrawal (Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar) score \>8) 3. Current suicidal or homicidal ideation and intent 4. Severe or unilateral violence in the past 6 months as measured by the Revised Conflict Tactics Scale (CTS2) (consistent with extant dyadic treatment literature).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05674409 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Alcohol Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05674409 currently recruiting?
Yes, NCT05674409 is actively recruiting participants. Contact the research team at sellersst@musc.edu for enrollment information.
Where is the NCT05674409 trial being conducted?
This trial is being conducted at Charleston, United States.
Who is sponsoring the NCT05674409 clinical trial?
NCT05674409 is sponsored by Medical University of South Carolina. The trial plans to enroll 400 participants.